• Regulatory NewsRegulatory News

    ICMRA: Address artificial intelligence challenges with permanent working group

    The rapid expansion and evolution of artificial intelligence (AI) will challenge the current regulatory pharmaceutical and device, according to a new horizon-scanning report from an international consortium of regulators. The ad hoc group recommends a permanent working group to stay abreast of the regulation of AI in the development and assessment of medicinal products.   A 6 August report from the International Coalition of Medicines Regulatory Authorities (ICMRA) d...
  • Regulatory NewsRegulatory News

    EFPIA, others question EC's proposed orphan and pediatric drug development updates

    An initiative by the European Commission (EC) to boost the development of pediatric drugs and medicines for people with rare diseases has received stakeholder feedback that in many cases expresses concern with the proposed upending of the status quo.   A 60-day period of public consultation for the initiative’s roadmap closed at the end of July; in all, 112 comments were received from individuals, non-governmental organizations (NGOs), public authorities, medical socie...
  • Regulatory NewsRegulatory News

    CTIS set to launch in EU; sponsor guide now online

    The European Commission (EC) has affirmed that it plans to launch the Clinical Trials Information System by the end of January 2022, as part of its broader efforts to modernize and streamline the conduct and oversight of clinical trials in the EU.   “The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards,” said Stella Kyriakides, EC commissioner for health and food safety, speaking o...
  • Regulatory NewsRegulatory News

    EMA updates reflection paper on GMP responsibilities of marketing authorization holders

    The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.   The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper , Regulatory Focus, 22 January 2020).   The paper covers the re...
  • ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • Regulatory NewsRegulatory News

    EMA addresses comparative quality assessment methods

    An updated reflection paper from the European Medicines Agency (EMA) tackles how statistics should be used in drug development when a comparative assessment of quality attributes needs to be made.   The paper touches on issues that arise both in the development of small molecules and in work being done in the area of biosimilars, where tricky manufacturing challenges and mutable organic molecules make defining the concept of “similarity” a challenge.   EMA’s human ...
  • ReconRecon

    Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug ( STAT ) AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push ( Fierce ) Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder ( STAT ) CDC to reverse ind...
  • Regulatory NewsRegulatory News

    EMA adopts guideline on quality documentation for drug-device combination products

    The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...
  • ReconRecon

    Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 ( NYT ) Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues ( Biopharma Dive ) Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player ( Endpoints ) House Democrats expand probe into political interference ...
  • Regulatory NewsRegulatory News

    Nouryant garners negative CHMP opinion for Parkinson's disease

    The human medicines committee of the European Medicines Agency (EMA) recommended two new medicines for approval during its July meeting; the committee also recommended four extensions of therapeutic indication and issued a negative opinion on one medicine.   Genzyme’s Nexviadyme (avalglucosidase alfa) was recommended by the Committee for Medicinal Products for Human Use (CHMP) to treat glycogen storage disease type II, also known as Pompe disease. Nexviadyme had receiv...
  • Regulatory NewsRegulatory News

    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...
  • Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...